# Wilson-Cook Medical Inc./Cook Endoscopy

- Location (FDA's records): Winston-Salem, NC
- FDA decisions: 7 (2012–2019): 7 510(k) clearances
- Product codes: KNS (3), NEU (1), FDX (1), FBK (1), PKL (1)
- 510(k) review time since 2016: median 260 days, against 62 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 8 (0 its own); citations of its devices by later devices: 9 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Wilson-Cook Medical, Inc.: 6 (https://510kreport.com/company/wilson-cook-medical)
- Carbon Medical Technologies, Inc.: 1 (https://510kreport.com/company/carbon-medical-technologies)
- Cook Endoscopy: 1 (https://510kreport.com/company/cook-endoscopy)

## Firms that cite its devices most
- Wilson-Cook Medical, Inc.: 5 (https://510kreport.com/company/wilson-cook-medical)
- Covidien: 1 (https://510kreport.com/company/covidien)
- Hangzhou AGS MedTech Co., Ltd.: 1 (https://510kreport.com/company/hangzhou-ags-medtech)
- Carbon Medical Technologies, Inc.: 1 (https://510kreport.com/company/carbon-medical-technologies)
- Olympus Medical Systems Corp.: 1 (https://510kreport.com/company/olympus-medical-systems)

## Its most-cited devices
- K111895: Echotip (R) Ultra Fiducial Needle (2012), cited by 3
- K172288: Fusion OMNI Sphincterotome (2018), cited by 2
- K172665: Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords (2018), cited by 2
- K121505: Disposable Hemostasis Chip (2012), cited by 1
- K171993: Zimmon Needle Knife Papillotome (2017), cited by 1

## Recent decisions
- K190829: Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) (Dec 19, 2019)
- K172665: Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords (May 24, 2018)
- K172288: Fusion OMNI Sphincterotome (Apr 17, 2018)
- K171993: Zimmon Needle Knife Papillotome (Aug 17, 2017)
- K171607: Bronchi and Gastrointestinal Cytology Brush (Jul 31, 2017)
- K121505: Disposable Hemostasis Chip (Aug 31, 2012)
- K111895: Echotip (R) Ultra Fiducial Needle (Apr 27, 2012)

Source page: https://510kreport.com/company/wilson-cook-medical-cook-endoscopy